# K173450: PRESS DUO elite, PRESS DUO elite AG

- Pathway: 510(k) (Traditional)
- Applicant: Nemoto Kyorindo Co., Ltd.
- Decided: Feb 7, 2018 after 93 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K934086 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963071: Angiomat Illumena, Mallinckrodt Inc., Liebel-Flarsheim Business (1997) Summary page 4.
- K133189: Dual Shot Alpha 7, Nemoto Kyorindo Co., Ltd. (2014) Summary page 4.
- K092896: Rempress and Angiography Contrast Delivery System Rempress, Nemoto Kyorindo Co., Ltd. (2010) Summary page 4.
- K132928: Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe, Medrad, Inc. / Bayer Medical Care, Inc. (2014) Summary page 4.

## Indications for use
The PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.

Source page: https://510kreport.com/device/K173450
Methodology: https://510kreport.com/methodology